Is cetirizine (antihistamine) safe to use during pregnancy?

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Cetirizine Safety During Pregnancy

Cetirizine is generally considered safe to use during pregnancy, particularly as a second-generation antihistamine of choice when antihistamine therapy is necessary. 1, 2

Safety Profile

  • Cetirizine is classified as an FDA Pregnancy Category B drug, indicating no evidence of harm to the fetus during pregnancy, although well-controlled human studies are limited 1
  • Multiple studies have not shown an association between cetirizine exposure during pregnancy and increased risk of adverse outcomes above background rates 3, 4
  • A meta-analysis of cetirizine studies showed no association with increased teratogenic risk 5

Recommendations for Use

  • When antihistamine therapy is necessary during pregnancy, second-generation antihistamines like cetirizine or loratadine are preferred options 1, 2
  • Cetirizine exposure primarily during the first trimester (when most organogenesis takes place) has not been associated with increased rates of congenital malformations 3, 4
  • A prospective observational cohort study found no significant differences in rates of:
    • Major birth defects
    • Spontaneous abortions
    • Preterm deliveries
    • Birth weight of term newborns 4

Important Considerations

  • The FDA drug label recommends consulting a healthcare professional before using cetirizine during pregnancy 6
  • While cetirizine is generally considered safe, it's best to avoid all antihistamines during pregnancy if possible, especially during the first trimester 1
  • If antihistamine therapy is necessary, cetirizine is one of the preferred options due to its established safety record 1, 2

Comparison with Other Antihistamines

  • Cetirizine has advantages over first-generation antihistamines like diphenhydramine:
    • Less sedating effects
    • No consistent association with birth defects 2
  • Cetirizine and loratadine are specifically recommended as the second-generation antihistamines of choice for allergic rhinitis during pregnancy 1

Dosing and Administration

  • Use the lowest effective dose for the shortest duration necessary
  • Monitor for maternal side effects, although these are less common with second-generation antihistamines like cetirizine
  • Consider non-pharmacological approaches first when possible

While no medication can be declared absolutely safe during pregnancy, the available evidence supports cetirizine as a relatively safe option when antihistamine therapy is necessary during pregnancy.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Antihistamine Use During Pregnancy

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Safety of cetirizine in pregnancy.

Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology, 2018

Research

The fetal safety of cetirizine: an observational cohort study and meta-analysis.

Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology, 2014

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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